Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0048—Eye, e.g. artificial tears
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/16—Amides, e.g. hydroxamic acids
  • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
  • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
  • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P23/00—Anaesthetics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P23/00—Anaesthetics
  • A61P23/02—Local anaesthetics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/02—Ophthalmic agents

Definitions

• the present invention relates to a composition set and a kit for use in intraocular surgery and which comprises a first and a second viscoelastic agent.
• the present invention has appeared in connection with intraocular operations, especially operations for cataract.
• composition set and kit which may be used in connection with other kinds of intraocular operations.
• the drops are given by nurses, and the surgeon may initiate the operation immediately when preparation in the form of washing and exposing has been performed by a nurse.
• the surgeon initiates the intervention by making a small incision in the eye at the rim of the cornea.
• intraocular anaesthesia is given by injection of about 0.2 ml in the anterior eye chamber at first.
• the viscoelastic agent is injected as an amount of about 0.2 ml in the anterior eye chamber. This is to prevent collapsing of the eye as well as giving protection to the back of the cornea during the operation.
• an opening is established at a second position along the rim of the cornea, the opening serving as access for the operation itself.
• a hole is made in the lens capsule (capsulorhexis), after which the lens is released in the capsule by means of liquid.
• the core and the cortex of the lens are removed with so-called Phaco emulsification and suction.
• Phaco emulsification and suction This implies that the lens is split up into smaller pieces that may be sucked out.
• the remaining capsule now appears as a sack suspended with thin threads (zonula threads). This sack is used as fixation of the new artificial lens in the posterior chamber of the eye right behind the pupil.
• the sack is filled with viscoelastic agent.
• the intraocular anaesthetic may possibly be supplemented before implantation of the lens.
• the viscoelastic agent is sucked out of the eye. The tightness of the wound is ensured, possibly by means of a suture, and hereafter the operation is finished.
• viscoelastic agents are used by routine, the agents comprising methyl hydroxypropyl cellulose, sodium hyaluronate, or sodium chondroitin sulphate, or mixtures thereof.
• the viscoelastic agents may be of different molecular weight and concentration and thereby different viscosity.
• Viscoelastics were initially prescription drugs but today they have status as over-the-counter drugs for use in intraocular surgery.
• the intraocular anaesthesia used for relieving this discomfort is a specially made product not made or known commercially. It will thus be necessary to suck up anaes- thesics into syringes which are transferred to the sterile preparation. There is a possibility of variation in the quality (purity and concentration) of the product made and an irrationality at the individual making of this anaesthesic. Furthermore, by the handling there is a not insignificant risk of contamination and maybe exchange by mistake as other syringes are also used at the operation.
• the quality of the product made is critical.
• the concentration is especially critical as experience shows that higher concentrations probably are toxic to the cornea.
• anaesthesia of the retina has been described.
• Intraocular anaesthesia is used because pressure changes occur in the eye during the operation, especially because of suction of the lens substance, or because manipulation may cause pull on iris, whereby the iris plate may move up and down, this being experienced as discomfort for the patient.
• the intraocular anaesthesia is thus used for removing discomfort for the patient provoked from the inner structure of the eye, so that the patient lies still even at oscillations in pressure by suction and by draught on iris, for example during implantation of the lens.
• the intraocular anaesthesia makes it possible to perform a more efficient eye operation. Thus it will be possible for more surgeons to master cataract operations with anaesthesia with drops in addition to that more patients may tolerate anaesthesia with drops. However, in many cases the intraocular anaesthesia is done without because of the risks connected with the proce- dure and the trouble connected with providing and making suitable mixtures of the used anaesthetics.
• composition set of the kind mentioned in the introduction which is characterised in that said first viscoelastic agent contains a concentration of at least one first anaesthetic suitable for use in inter- nal viscoanaesthesia and that said second viscoelastic agent contains a concentration of at least one second anaesthetic suitable for use in external viscoanaesthesia.
• the kit of the kind mentioned in the introduction is characterised in that it comprises - a sterile packaged first hypodermic syringe containing the first viscoelastic agent including at least a first anaesthetic and a hypodermic needle ready for injection, and which is used for internal viscoanaesthesia and - a second hypodermic syringe containing said second viscoelastic agent as well with a second anaesthetic admixed therein and which is used for external viscoanaesthesia.
• composition set By using such a composition set and such a kit it becomes possible to perform an operation with application of a method that may be called viscoanaesthesia. This is achie- ved by using anaesthetics contained in said first and said second viscoelastic agents which are provided in a ready-to-use condition.
• the external viscoanaesthesia is applied only one time about 5 minutes earlier to the start of the surgery. Accordingly, the nurse who gives the external viscoanaestehesia may prepare the patient in the waiting time and may announce that the patient is ready for the surgeon. Thus, the surgeon will be ready to work at the patient immideately. Moreover time is saved seeing that the intraocular anaesthesia is given as a part of the steps performed by the surgeon during the surgical intervention.
• anaesthetic in the eye is ensured with the possibility of a gradual release of the anaesthetic as long as the viscoelastic solution is present in the eye.
• composition set according to the invention it thus becomes possible to perform intraocular anaesthesia simultaneously with introducing the viscoelastic agent which in a traditional way is injected for protecting the inner of the eye and for expanding the eye and for aiding during the lens implantation.
• composition set according to the invention it thus becomes possible to reduce two procedures into a single procedure with the consequent reduction of risks of contamination and erroneous concentration.
• composition set according to the invention is characterised in that said anaesthetics comprise lidocaine hydrochloride with a concentration between 0.5 and 5 %, preferably 1 %, that as viscoelastic agents sodium hyaluronate is used, and that sodium hyaluronate is used in concentrations between 5 and 40 mg/ml, preferably between 10 and 20 mg/ml, in Ringer lactate solution or Basic Salt Solution
• composition set is characterised in that said first viscoelastic agent is sodium hyluronate comprising as anasthethic agent lidocaine hydrochloride in a concentration between 0.5 and 5 %, preferably 1 %, and that said second viscoelastic agent is sodium hyluronate comprising as anasthethic agent lidocaine hydrochloride in a concentration between 2 and 6 %, preferably 4 %.
• the composition is pH-adjusted and adjusted with respect to osmosis and salt. This takes places preferably with sodium bicarbonate and pH is adjusted to about 7.
• sodium hyaluronate or sodium chondroitinsulphate as viscoelastics.
• the viscoelastic agents may be viscoelastic polymers and may be of the type and have physical properties as disclosed in WO 98/41 171, the content of which is hereby incorporated by reference.
• An especially appropriate range of shear viscosities for the compositions according to the present invention measured at a shear rate of 39.6s A -l is 5 to 500 cP, preferably about 200 cP.
• composition set in the form of a kit which comprises a sterile packaged first hypodermic syringe containing the first viscoelastic agent including at least a first anaesthetic and a hypodermic needle ready for injection, and which is used for internal viscoanaesthesia and a second hypodermic syringe containing said second viscoelastic agent as well with a second anaesthetic admixed therein and which is used for external viscoanaesthesia.
• the surgeon may thus provide a kit which after the end of op- eration may be discarded.
• the syringe will preferably be arranged for containing between 0.3 and 1.0 ml.
• kit may contain a first and a second syringe each with a viscoelastic agent containing an anaesthetic for use in anaesthesia it becomes possible to have an anaesthes- tic kit for the whole surgical intervention.
• the second syringe may preferably contain lidocaine hydrochloride in a higher concentration than the first syringe used intraocularily.
• said first syringe comprises sodium hyaluronate with lidocaine hydrochloride in a concentration between 0.5 and 5%, preferably 1%
• the second syringe comprises sodium hyaluronate with lidocaine hydrochloride in a concentration between 2 and 6%, preferably 4% allowing surface analgesia.
• the first and the second syringes contain sodium hyaluronate or mixtures of other viscoelastica in concentrations between 5 and 40 mg/ml, preferably between 10 and 20 mg/ml.
• the viscoelastic anaesthesian mixture in the second syringe is applied externally in conjunctiva between the lower eyelid and the eyeball approximately 5 minutes before commencing the operation.
• the patient lies with the eye shut until the operation is commenced.
• the viscoelastic mixture ensures a good and permanent release of the anaesthestic and the viscoelastic mixture ensures a clear cornea. Also it may be expected that a deeper anaesthesia is achieved by using a viscoelastic agent instead of traditional drops.
• the external anaesthesia may possibly be provided at the start of the operation whereby not only the anaesthesia is enhanced, but the cornea is protected against dry- ing out, which implies less need for flushing with liquid during the operation (lubricating effect).
• the second syringe is used for an external vis- coanaesthesia which is then replacing the anaesthesia with drops.
• the first syringe in such a kit is used for an internal viscoanaesthesia instead of the traditional intraocular anaesthesia.
• composition set and the kit according to the present invention there is thus introduced the above defined new terms in the form of external viscoanaesthesia and internal viscoanaesthesia.
• the operation may thus be performed using the method designated viscoanaesthesia.
• the two syringes will visually differ from each other so that the user does not mistake the two syringes.
• the differentiation may be established by size, colour, shape, or in another way.
• the syringe intended for external viscoanaesthesia will contain a mixed product with a relatively high concentration of anaesthesia and a relatively low viscosity which is depending on the concentration and kind of viscoelastic agent. Contrary to this, the syringe for internal viscoanaesthesia will contain an agent with a relatively low concentration of anaesthesia and a relatively high viscosity depending on the concentration and kind of viscoelastic agent.
• the agent contained in each of the syringes may well be present without any preservation agents so that a risk of toxicity to the cornea is avoided.
• viscoanaesthesia a simplified operation and an experience of less discomfort on the patient is achieved.
• used as viscoelastics are methyl hydroxypropyl cellulose, sodium hyaluronate, or sodium chondroitinsulphate, or mixtures thereof, or other viscoelastic agents for use in connection with intraocular operations. Concentrations between 5 and 40 mg/ml, preferably between 10 and 20 mg/ml, are used.
• a composition set or a kit according to the invention may alternatively be used in connection with other surgical interventions than cataract operations. Alternatively, it may thus be used by other kinds of intraocular operations where a viscoelastic agent is applied.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Veterinary Medicine (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Epidemiology (AREA)
• Ophthalmology & Optometry (AREA)
• Organic Chemistry (AREA)
• Anesthesiology (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Inorganic Chemistry (AREA)
• Pain & Pain Management (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Engineering & Computer Science (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Prostheses (AREA)
• Medicinal Preparation (AREA)

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• 1998
  • 1998-12-18 DK DK199801679A patent/DK172900B1/da not_active IP Right Cessation
• 1999
  • 1999-12-13 US US09/868,136 patent/US6627620B1/en not_active Expired - Lifetime
  • 1999-12-13 CN CNB998156043A patent/CN1197550C/zh not_active Expired - Fee Related
  • 1999-12-13 BR BR9916358-6A patent/BR9916358A/pt not_active Application Discontinuation
  • 1999-12-13 CA CA002353835A patent/CA2353835C/en not_active Expired - Fee Related
  • 1999-12-13 ES ES99957971T patent/ES2249923T3/es not_active Expired - Lifetime
  • 1999-12-13 AU AU15502/00A patent/AU782528B2/en not_active Expired
  • 1999-12-13 DE DE69927176T patent/DE69927176T2/de not_active Expired - Lifetime
  • 1999-12-13 EP EP99957971A patent/EP1140016B1/de not_active Expired - Lifetime
  • 1999-12-13 DK DK99957971T patent/DK1140016T3/da active
  • 1999-12-13 WO PCT/DK1999/000695 patent/WO2000037047A1/en active IP Right Grant
  • 1999-12-13 JP JP2000589158A patent/JP2002532534A/ja active Pending
  • 1999-12-13 IL IL14369899A patent/IL143698A0/xx active IP Right Grant
  • 1999-12-13 AT AT99957971T patent/ATE303794T1/de active
  • 1999-12-13 PL PL349372A patent/PL195128B1/pl not_active IP Right Cessation
• 2001
  • 2001-06-12 IL IL143698A patent/IL143698A/en not_active IP Right Cessation
• 2002
  • 2002-05-07 HK HK02103443.5A patent/HK1041651B/zh not_active IP Right Cessation

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